Pembrolizumab and Odetiglucan in Liver Predominant Metastatic Colorectal Adenocarcinoma

NCT07082439 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: UPCC 05225
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the safety and effectiveness of the combination of pembrolizumab and odetiglucan in patients with metastatic colorectal cancer that is predominantly in the liver.

Conditions

Colorectal Adenocarcinoma Metastatic in the Liver

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR)

  Proportion of patients with best response as complete response (CR) or PR (partial response) using RECIST v. 1.1.

  Up to 2 years

Secondary Outcomes (7)

• ORR iRECIST

  Up to 2 years.

• ORR Liver by iRECIST

  Up to 2 years.

• Duration of response

  From date of first CR or PR by iRECIST until disease progression or death, whichever comes first, assessed up to 4 years.

• Disease control rate

  Up to 2 years.

• Progression free survival

  From date of enrollment to first documented disease progression or date of death from any cause, whichever came first, assessed up to 4 years.

Study Arms (1)

Pembrolizumab and Odetiglucan

EXPERIMENTAL

Drug: Pembrolizumab; Drug: Odetiglucan

Interventions

Pembrolizumab DRUG

Pembrolizumab 200 mg intravenous administration on day 1 of each 3-week cycle until disease progression, unacceptable toxicity or participant withdrawal. Participants who complete study intervention after 2 years of pembrolizumab and odetiglucan without disease progression and subsequently experience disease progression while off of treatment are eligible for up to 1 year of additional pembrolizumab and odetiglucan (second course).

Pembrolizumab and Odetiglucan

Odetiglucan DRUG

Odetiglucan 4 mg/kg intravenous administration on day 1 of each 3-week cycle until disease progression, unacceptable toxicity or participant withdrawal. Participants who complete study intervention after 2 years of pembrolizumab and odetiglucan without disease progression and subsequently experience disease progression while off of treatment are eligible for up to 1 year of additional pembrolizumab and odetiglucan (second course).

Pembrolizumab and Odetiglucan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male/female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of metastatic colorectal adenocarcinoma with liver-predominant disease, defined as liver metastases with
• No symptomatic lung or bony metastases
• No peritoneal carcinomatosis or clinically significant ascites as determined by the investigator Note: at least 1 measurable lesion must be present in the liver to assess response. It is preferable to have at least 1 other lesion present in the liver which can be biopsied. Measurable lesions chosen as target lesions in the liver should not be biopsied if it can be avoided
• Patient must have received prior treatment with a fluoropyrimidine, oxaliplatin, irinotecan, and a VEGF inhibitor (e.g., bevacizumab), unless contraindicated.
• Patients with KRAS/NRAS/BRAF wild-type cancers must also have received an EGFR inhibitor (e.g., cetuximab or panitumumab) in addition to the aforementioned therapies, unless contraindicated.
• Patients who experienced disease recurrence within 6 months of oxaliplatin-containing adjuvant therapy will qualify as having received an oxaliplatin-containing regimen in the metastatic setting.
• Tumor must have documented mismatch repair proficiency (MMR proficient) by immunohistochemistry or not microsatellite instability high(non-MSI-H) by PCR.
• Participants who have adverse events due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy or persistent alopecia are eligible.
• The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention.
• Have a life expectancy of 3 months or greater as assessed by the investigator
• Have adequate organ function. Specimens must be collected within 14 days prior to the start of study intervention.
• Male participants: A male participant must agree to use a contraception during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.
• A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
• Not a woman of childbearing potential (WOCBP) OR

You may not qualify if:

• WOCBP who has a positive urine pregnancy test within 72 hours prior to receiving the first dose of study medication (see Appendix 3). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. If the serum pregnancy test is negative, then the participant will be deemed eligible on this criterion.
• Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
• Has previous treatment with odetiglucan
• Has received prior systemic anti-cancer therapy including investigational agents within 2 weeks prior to first dose of study treatment.
• Has received prior radiotherapy within 2 weeks of start of study intervention or has ongoing radiation-related toxicities requiring corticosteroids.
• Note: Two weeks or fewer of palliative radiotherapy for non-CNS disease, with a 1-week washout, is permitted.
• Has undergone treatment chemoembolization or radioembolization within 6 weeks prior to enrollment on the study
• Has undergone hepatic arterial infusion pump placement
• Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
• Has received an investigational agent or has used an investigational device within the shorter of 4 weeks or 5 half-lives of the first dose of study intervention administration.
• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
• Known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded.
• Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention.
• Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
• Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid)

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Abramson Cancer Center at the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Interventions

pembrolizumab

Study Officials

• William Chapin, MD, MSCE

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark O'Hara, MD

CONTACT

215-360-0919; Mark.OHara@pennmedicine.upenn.edu

William Chapin, MD, MSCE

CONTACT

215-662-7606; William.Chapin@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: July 24, 2025
• Study Start: September 10, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2029
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning 3 months following clinical trial publication. No end date.
• Access Criteria: To achieve aims in an approved proposal. Proposals should be directed to corresponding author on the clinical trial publication.

Locations

US (1)